The tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.The antibody test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens and,. The antigen test has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens.The COVID/Flu/RSV test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV), and not for any other viruses or pathogens.The COVID/Flu molecular test and self-collection kit have been authorized only for the unsupervised self-collection and maintenance of nasal specimens for as an aid in detection of nucleic acid from SARS-CoV-2 and influenza A virus and influenza B virus, not for any other viruses or pathogens.The molecular tests have been authorized only for the unsupervised self-collection and maintenance of nasal specimens for the detection of nucleic acid from SARS CoV-2, not for any other viruses or pathogens.The tests have been authorized by FDA under an EUA for use by authorized laboratories.The Quest Diagnostics molecular test, the other authorized molecular tests and the self-collection kit (together the “molecular tests”), the COVID/Flu molecular test and self-collection kit, the COVID/Flu/RSV test, the antigen test and the antibody test (together “the tests”) have not been FDA cleared or approved.
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